US20230225890A1 - Stent graft delivery system inclduing a tapered tip offset through-channel aligning with a first guidewire lumen - Google Patents
Stent graft delivery system inclduing a tapered tip offset through-channel aligning with a first guidewire lumen Download PDFInfo
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- US20230225890A1 US20230225890A1 US18/119,666 US202318119666A US2023225890A1 US 20230225890 A1 US20230225890 A1 US 20230225890A1 US 202318119666 A US202318119666 A US 202318119666A US 2023225890 A1 US2023225890 A1 US 2023225890A1
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- stent graft
- tapered tip
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Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
- A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
- A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
- A61F2/9661—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod the proximal portion of the stent or stent-graft is released first
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
- A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
- A61F2002/9665—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod with additional retaining means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
Definitions
- the present disclosure relates to a delivery system for stent graft.
- the stent graft delivery system includes a tapered tip offset through-channel aligning with a first guidewire lumen.
- a stent graft is an implantable device made of a tube-shaped surgical graft covering and an expanding or self-expanding metal frame.
- the stent graft is placed inside a blood vessel to bridge, for example, an aneurismal, dissected, or other diseased segment of the blood vessel, and, thereby, exclude the hemodynamic pressures of blood flow from the diseased segment of a blood vessel such as the aorta.
- the aneurysm may extend into areas having vessel bifurcations or segments of the aorta from which smaller “branch” arteries extend.
- thoracic aortic aneurysms can include aneurysms present in the ascending thoracic aorta, the aortic arch, and/or branch arteries that emanate therefrom, such as subclavian or left or right common carotid arteries.
- a branched stent graft can be used to treat such aneurysms.
- a main stent graft can be deployed in the main vessel (e.g., aortic arch), and a supplemental, secondary stent graft can be deployed in the branched artery (e.g., left subclavian).
- main vessel e.g., aortic arch
- secondary stent graft e.g., left subclavian
- a stent graft delivery system includes a stent graft cover having a central longitudinal axis.
- the stent graft cover houses a first guidewire lumen extending along a first guidewire lumen axis and configured to track along a first guidewire.
- the first guidewire lumen axis is offset the central longitudinal axis.
- the stent graft delivery system further includes a tapered tip extending distally from the stent graft cover and defining an offset through-channel extending within the tapered tip along a tapered tip offset axis and configured to track along the first guidewire.
- the first guidewire lumen axis and the tapered tip offset axis extend along a common axis.
- a stent graft delivery system includes a first guidewire lumen extending along a first guidewire lumen axis and is configured to track along a first guidewire.
- the system also includes a tapered tip defining an offset through-channel extending within the tapered tip along a tapered tip offset axis and configured to track along the first guidewire.
- the first guidewire lumen axis and the tapered tip offset axis extend along a common axis.
- a stent graft delivery system comprises a first guidewire lumen extending along a first guidewire lumen axis and configured to track along a first guidewire.
- the stent graft delivery system further includes a tapered tip defining an offset through-channel extending within the tapered tip along a tapered tip offset axis and configured to track along the first guidewire.
- the first guidewire lumen and the offset through-channel are fixed in alignment to receive the first guidewire.
- FIG. 1 is a schematic illustration of a stent graft delivery system, according to one embodiment.
- FIG. 2 is a rear perspective view of a distal end of the delivery system with an inner member removed and a stent graft cover partially transparent for view of the inner components, according to one embodiment.
- FIG. 3 is a rear view of the distal end of the delivery system from inside the delivery system, according to one embodiment.
- FIG. 4 is a side elevation view of the distal end of the delivery system with an opening in the stent graft cover for view of the inner components, according to one embodiment.
- FIG. 5 is a cross-sectional view of the distal end of the delivery system, according to one embodiment.
- FIG. 6 is a side view of a spindle configured to be positioned within the distal end of the delivery system, according to one embodiment.
- FIG. 7 is a side view of the spindle of FIG. 6 placed about an inner member of the delivery system, according to one embodiment.
- FIG. 8 is a cross-sectional view of the tapered tip of the delivery system having a profile according to one embodiment.
- FIG. 9 is a cross-sectional view of the tapered tip of the delivery system having a profile according to another embodiment.
- FIG. 10 is a cross-sectional view of the tapered tip of the delivery system having a profile according to another embodiment.
- distal and proximal are used in the following description with respect to a position or direction relative to a treating clinician. “Distal” and “distally” are positions distant from or in a direction away from the clinician, and “proximal” and “proximally” are positions near or in a direction toward the clinician.
- proximal is the portion nearer the heart by way of blood flow path while “distal” is the portion of the stent-graft further from the heart by way of blood flow path.
- Thoracic aortic aneurysms with disease progression extending into the aortic arch can be treated with a branched stent graft and delivery system.
- Branched stent graft delivery systems can be used to deliver and deploy stent grafts that are configured to couple with secondary stent grafts that extend into vessels or “branches” within a patient's vasculature, such as the thoracic aorta.
- a main guidewire may be fed into the vasculature and into a main vessel (e.g., aortic arch), and a secondary guidewire may be fed into a secondary vessel or branched artery (e.g., left subclavian).
- the stent graft delivery system can include a main lumen that tracks along the main guidewire, and a secondary lumen that tracks along the secondary guidewire.
- a main stent graft can be deployed in a main vessel, and a supplemental, secondary stent graft can be deployed in the branched artery.
- An example of such a surgical procedure is described in U.S. patent application Ser. No. 16/828,644 titled Branched Stent Graft Delivery System, which is hereby incorporated by reference.
- FIG. 1 shows a branched stent graft delivery system 10 according to one embodiment.
- the branched stent graft delivery system 10 also more simply referred to as a stent graft delivery system or a delivery system, includes an endovascular catheter and extends between a proximal end 12 and a distal end 14 .
- proximal end and distal end are not intended to be limiting, as a surgical clinician may, during a procedure, in fact be located closer to the distal end 14 than the proximal end 12 . Therefore, the proximal end and the distal end may be referred to as a “first end” and a “second end,” respectively.
- a threaded screw gear 16 extends along an axis between the proximal end 12 and the distal end 14 .
- the threaded screw gear may be a multi-part shell configured to connect together to make a tubular screw gear.
- the screw gear 16 is two half-shells configured to connect (e.g., snap or assemble) together.
- a handle assembly 18 is provided for grip by the clinician.
- the handle assembly 18 may include two separable portions, namely a front grip 20 and an external slider 22 .
- the front grip 20 may be fixed relative to the screw gear 16
- the external slider 22 may rotate about a threaded outer surface of the screw gear 16 to move linearly along the screw gear 16 .
- the external slider 22 is rotated to move toward the proximal end 12 . Since the external slider 22 is operatively coupled to a stent graft cover 24 surrounding the stent graft, the stent graft cover 24 is retracted with the linear movement of the external slider 22 .
- a tip 26 at the distal end 14 of the delivery system 10 which has openings to track over the guidewires, can remain steady within the vessel as the stent graft cover 24 is retracted away from the tip 26 . Retraction of the stent graft cover 24 allows the stent graft to expand within the patient's vessel. Once the stent graft is deployed, the entire stent graft delivery system 10 may be retracted from the patent's vessel.
- the stent graft can be self-expanding, in that it includes structures that are shaped or formed from a material that can be provided with a mechanical memory to return the structure from a compressed or constricted delivery configuration to an expanded deployed configuration.
- the stent graft can include two main components: a tubular graft, and one or more stents for supporting and expanding the graft.
- the graft may be formed from any suitable graft material, for example and not limited to, a low-porosity woven or knit polyester, DACRON material, expanded polytetrafluoroethylene, polyurethane, silicone, or other suitable materials.
- the graft material can also be a natural material such as pericardium or another membranous tissue such as intestinal submucosa.
- the stent is radially-compressible and expandable, is coupled to the graft material for supporting the graft material, and is operable to self-expand into apposition with the interior wall of a body vessel (not shown).
- Each stent can be constructed from a self-expanding or spring material, such as but not limited to Nitinol, stainless steel, a pseudo-elastic metal such as a nickel titanium alloy or nitinol, various polymers, or a so-called super alloy, which may have a base metal of nickel, cobalt, chromium, or other metal, or other suitable material.
- the stent may be a sinusoidal patterned ring including a plurality of crowns or bends and a plurality of struts or straight segments with each crown being formed between a pair of opposing struts.
- screw gear 16 is illustrated and described herein as having a threaded outer surface, it should be understood that in other embodiments, the screw gear is not threaded, the external slider 22 can slide linearly along the screw gear, or any other suitable mechanism may be used to retract the graft cover.
- the stent graft delivery system 10 may also include an access port 28 .
- the access port 28 provides an opening for insertion, removal, or receiving of a secondary guidewire lumen, or branching lumen, for surrounding a secondary guidewire.
- the delivery system 10 can track along both the main guidewire and the secondary guidewire during delivery of the stent graft.
- FIGS. 2 - 5 illustrate various views of internal components of a distal end 100 of a stent graft delivery system, such as that illustrated in FIG. 1 .
- the structure shown in FIGS. 2 - 5 and described below can be substituted for the distal end 14 of FIG. 1 .
- the distal end 100 includes a tip 102 , also referred to as a tapered tip due to its tapered profile.
- the tapered tip 102 provides a leading edge of the delivery system 10 , and tracks over one or more guidewires.
- the tapered tip 102 includes a leading edge or front surface 104 that defines a cut-out or opening 106 configured to receive a main guidewire.
- the opening 106 can be an aperture in the material of the tapered tip 102 with an inner surface of the tapered tip 102 surrounding the main guidewire.
- the opening 106 is aligned with an inner member 108 within the stent graft cover 24 , as will be described below.
- the tapered tip 102 can also include a second opening 110 configured to receive a secondary guidewire.
- This second opening 110 allows the delivery system 10 to track over the secondary guidewire simultaneously with the main guidewire.
- the second opening 110 is aligned with a secondary lumen 112 within the stent graft cover 24 , as will be described below.
- the stent graft cover 24 is the outer-most sheath or lumen of the stent graft delivery system.
- the stent graft cover initially contains or surrounds a proximal portion of the tapered tip 102 , as well as the inner member 108 , the secondary lumen 112 , and a stent graft (not shown).
- the surgical technician may utilize the handle to retract the stent graft cover 24 , allowing the stent graft to deploy.
- the stent graft cover 24 is an elongate tubular member defining a lumen from a proximal end to a distal end thereof.
- the stent graft cover 24 may be formed from a plurality of different materials or combination of materials; in one embodiment, the stent graft cover 24 is formed with a braided stainless steel wire with a flat or rounded cross section that is sandwiched between layers of PEBAX® or VESTAMID®.
- the inner member 108 defines a hollow lumen, and can be two parts.
- the inner member 108 can include an inner lumen or guidewire lumen 114 , and an outer lumen or capture lumen 116 .
- Each of the guidewire lumen 114 and the capture lumen 116 may be made from a high tensile polymer, such as polyether ether ketone (PEEK) or a polyimide.
- PEEK polyether ether ketone
- the capture lumen 116 is larger than the guidewire lumen 114 and receives the guidewire lumen 114 therein.
- the guidewire lumen 114 may be fixed to the tapered tip 102 , while the capture lumen 116 may be slideable along the outer surface of the guidewire lumen to slide toward the proximal end of the delivery system 10 .
- the guidewire lumen 114 may be fixed in alignment with the opening 106 of the tapered tip 102 to receive the main guidewire therethrough and track along the main guidewire during insertion into the patient
- the delivery system also includes a tip capture mechanism, shown generally at 120 .
- the tip capture mechanism 120 is coupled to, and actuated by, the inner member 108 .
- the tip capture mechanism 120 includes a capture fitting 122 having a plurality of fingers 124 or prongs.
- the capture fitting 122 is configured to hold a stent, ring, loop, or other such structure of a proximal end of the stent graft. This allows the stent graft to be deployed (e.g., when the stent graft cover 24 is retracted) while its proximal end is held in a constricted manner during deployment.
- a proximal end of the capture fitting 122 is fixed to the capture lumen 116 to move with the capture lumen 116 .
- the capture lumen 116 can be slid toward the surgical technician relative to the guidewire lumen 114 , thereby releasing the fingers 124 of the tip capture fitting 122 from the stent, ring, loop, or the like of the stent graft. This releases the stent graft from the delivery system, and the entire catheter can then be removed from the patient. While one example of a tip capture mechanism has been described, any tip capture mechanism may be compatible with the present disclosure.
- the tip capture mechanism may be configured such that the inner tube extends axially forward to move the tip forward relative to the outer tube and spindle, thereby releasing the stent graft.
- Other tip capture mechanisms may include a single tube, three or more tubes, or other systems.
- the secondary lumen 112 is also provided within the stent graft cover 24 .
- the secondary lumen 112 is aligned with the opening 110 to receive the secondary guidewire therethrough, and track along the secondary guidewire during insertion into the patient's vasculature.
- the secondary lumen may be located radially outboard of the inner member 108 , but radially inward of the stent graft cover 24 .
- a secondary lumen within the confines of the stent graft could present several issues. For example, packaging constraints within the delivery system would be compromised, requiring other components within the confines of the stent graft to be reduced in size while still maintaining feasibility. Moreover, a bulge could be created in the stent graft cover as the secondary lumen is bent around the stent graft components. Such a bulge can make the profile of the delivery system lager than the intended outer profile. There is also difficulty in maintaining alignment of the secondary lumen and the inner components. In many cases, the secondary lumen is forced to bend around the arms of the capture mechanism and can become bent or misshapen in a way that could compromise the lumen patency or at least increase wire friction through the lumen.
- the tapered tip 102 is designed to allow for smaller components within the confines of the stent graft cover 24 .
- the front surface 104 and the opening 106 at the distal end of the tapered tip 102 is not concentric with the stent graft cover 24 .
- These components can be offset from center in a direction away from the secondary lumen 112 , giving more space for the secondary lumen 112 to assume and not be bent or create a bulge in the stent graft cover 24 . Also, this allows an easier retraction of the secondary lumen 112 , if necessary, during a surgical deployment prior to retraction of the stent graft cover 24 .
- the nature of the offset can be seen in the FIGS. 4 and 5 , and in particular FIG. 4 .
- the distal surface or front surface 104 , the opening 106 , the inner member 108 , and the tip capture mechanism 120 are all concentric and have a common first central axis 130 .
- the stent graft cover 24 has a second central axis 132 that is offset from the first central axis 130 .
- the secondary lumen 112 is positioned toward the perimeter (e.g., touching or adjacent) of the stent graft cover 24 .
- the first central axis 130 is located away from the second central axis 132 in a direction away from the second central axis 132 . While the terms “first” and “second” are used herein, it should be understood that these terms are used merely to delineate and label the two components separately, and the terms can be interchangeable.
- the internal components may be reduced in size.
- the tip capture mechanism 120 may be reduced in size, to allow the components to be offset from their original, central positioning. This creates more space for the secondary lumen 112 .
- the tapered tip 102 also allows for the tapered tip 102 to be assembled to (e.g., pressed into) the delivery system late in the assembly process, in which the tapered tip 102 can be precisely positioned, rotationally, to optimize engagement with the secondary lumen 112 .
- the tapered tip 102 can be assembled to the remainder of the delivery system at a rotational alignment such that the opening 110 is aligned with the secondary lumen 112 .
- a spindle 140 is provided.
- the spindle 140 is a barbed insert for attachment of the tapered tip 102 to the inner member 108 .
- the spindle 140 is shown in the cross-sectional view in FIG. 5 , in isolation in FIG. 6 and attached about the guidewire lumen 114 in FIG. 7 .
- the spindle 140 is configured to align with the tip capture device 120 along the first central axis 130 to hold the stent graft in place during delivery (e.g., the stent apices may be held between the spindle 140 and the capture fitting 122 ).
- the spindle 140 is fixed to the tapered tip 102 , and does not move with the capture lumen 116 or stent graft cover 24 during deployment of the stent graft. In previous designs, a spindle was overmolded onto a tapered tip, but this can create difficulty with non-concentric arrangements. Instead, in embodiments herein the spindle 140 is a separate component and separately assembled to the tapered tip 102 .
- a portion of the delivery system may be pre-assembled or pre-loaded such that the tapered tip 102 may be assembled to the guidewire lumen 114 , which is inserted into the capture lumen 116 , and the tapered tip 102 is pressed onto the spindle 140 .
- the tapered tip 102 may be formed to include an inner surface 142 that creates a widened portion of the opening 106 at a proximal end of the tapered tip 102 .
- the inner surface 142 of the widened opening can be pressed around and fit about an exterior surface 144 of the spindle 140 .
- the exterior surface 144 of the spindle 140 may be provided with surface features configured to inhibit movement.
- the exterior surface 144 can include a first set of barbs 146 and a second set of barbs 148 .
- the first set of barbs 146 may include one or more fins, projections, or the like that extend annularly about the first central axis 130 .
- these barbs 146 may be formed to be angled such that a proximal end of the barbs 146 extends further radially outward compared to a distal end of the barb 146 . This angle inhibits the tapered tip 102 from pulling away from the spindle 140 after assembly.
- the barbs 146 may be flattened or otherwise compressed once the tapered tip 102 is pressed over the barbs 146 .
- the second set of barbs 148 may include one or more circumferentially-spaced fins each extending in an axial direction along the exterior surface 144 . These barbs 148 are configured to inhibit rotation between the tapered tip 102 and the spindle 140 .
- the exterior surface of the guidewire lumen 114 may be provided with one or more barbs 150 .
- the barbs 150 may be similar to the first set of barbs 146 , being disposed annularly about the first central axis 130 .
- the guidewire lumen 114 may also be provided with one or more barb that is similar in design to the second set of barbs 148 .
- the offset-axis relationship of the delivery system can yield a tapered tip with varying thicknesses of material.
- the tapered tip 102 has a thicker amount of material above the opening 106 than below. Said another way, there is more material of the tapered tip on the side of the first central axis 130 closer to the second opening 110 than the other side of the first central axis 130 .
- the first central axis 130 is not the centerline of the taper of the tapered tip 102 .
- FIGS. 8 - 10 illustrate various embodiments for varying the thickness of the tapered tip on either side of the opening 106 . Varying the shape or thickness of the tapered tip 102 can provide a preferential bending direction during insertion into the vasculature.
- FIGS. 8 - 10 include the structure of the tapered tip 102 described above, unless described otherwise.
- FIG. 8 shows a tapered tip 102 ′ according to one embodiment.
- the tapered tip 102 ′ has a first portion 160 on the side of the opening 106 closer to the second opening 110 , and a second portion 162 on the side of the opening 106 away from the second opening 110 .
- the first portion 160 is generally conical in shape, generally constantly increasing in thickness (e.g., between the opening 106 and the outer surface) from the front surface 104 toward the rear.
- the outer surface of the first portion 160 is generally linear.
- the second portion 162 has an outer surface that is concave. Therefore, the second portion 162 is not generally conical in shape, as the thickness of the second portion is not constant. This can influence the tracking performance of the delivery system in a first manner, with a first preferred bending direction that may allow for easier tracking and device placement.
- FIG. 9 shows a tapered tip 102 ′′ according to another embodiment.
- the tapered tip 102 ′′ has a first portion 170 on the side of the opening 106 closer to the second opening 110 , and a second portion 172 on the side of the opening 106 away from the second opening 110 .
- the first portion 170 has an outer surface that is generally concave
- the second portion 172 has an outer surface that is generally concave.
- the outer surfaces of the two portions 170 , 172 can be pitched or concave at different degrees of magnitude.
- the second portion 172 can be more concave than the first portion 170 .
- both the first and second portions 170 , 172 can be angled such that the thickness of both portions is equal or substantially similar for at least a majority of the length of the portions 170 , 172 . This can influence the tracking performance of the delivery system in another manner, with another preferred bending direction that may allow for easier tracking and device placement.
- FIG. 10 shows a tapered tip 102 ′′′ according to another embodiment.
- the tapered tip 102 ′′′ has a first portion 180 on the side of the opening 106 closer to the second opening 110 , and a second portion 182 on the side of the opening 106 away from the second opening 110 .
- the second portion 182 may have an outer surface that is generally linear, creating a conical shape of the second portion 182 .
- the outer surface of the first portion 170 may be concave.
- the thickness of the second portion 182 may exceed the thickness of the first portion 180 for at least a majority of the length of the portions 180 , 182 . This can influence the tracking performance of the delivery system in another manner, with another preferred bending direction that may allow for easier tracking and device placement.
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
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- Gastroenterology & Hepatology (AREA)
- Pulmonology (AREA)
- Prostheses (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
A stent graft delivery system. The system includes a stent graft cover having a central longitudinal axis. The stent graft cover houses a first guidewire lumen extending along a first guidewire lumen axis and configured to track along a first guidewire. The first guidewire lumen axis is offset the central longitudinal axis. The stent graft delivery system further includes a tapered tip extending distally from the stent graft cover and defining an offset through-channel extending within the tapered tip along a tapered tip offset axis and configured to track along the first guidewire. The first guidewire lumen axis and the tapered tip offset axis extend along a common axis.
Description
- This application is a continuation of U.S. application Ser. No. 16/862,720 filed Apr. 30, 2020, now U.S. Pat. No. ______ which issued on ______, the disclosure of which is hereby incorporated in its entirety by reference herein.
- The present disclosure relates to a delivery system for stent graft. In one or more embodiments, the stent graft delivery system includes a tapered tip offset through-channel aligning with a first guidewire lumen.
- The use of endovascular procedures has been established as a minimally invasive technique to deliver a variety of clinical treatments in a patient's vasculature. A stent graft is an implantable device made of a tube-shaped surgical graft covering and an expanding or self-expanding metal frame. The stent graft is placed inside a blood vessel to bridge, for example, an aneurismal, dissected, or other diseased segment of the blood vessel, and, thereby, exclude the hemodynamic pressures of blood flow from the diseased segment of a blood vessel such as the aorta.
- Depending on the region of the aorta involved, the aneurysm may extend into areas having vessel bifurcations or segments of the aorta from which smaller “branch” arteries extend. For example, thoracic aortic aneurysms can include aneurysms present in the ascending thoracic aorta, the aortic arch, and/or branch arteries that emanate therefrom, such as subclavian or left or right common carotid arteries. In some cases, a branched stent graft can be used to treat such aneurysms. For example, a main stent graft can be deployed in the main vessel (e.g., aortic arch), and a supplemental, secondary stent graft can be deployed in the branched artery (e.g., left subclavian).
- According to an embodiment, a stent graft delivery system is disclosed. The system includes a stent graft cover having a central longitudinal axis. The stent graft cover houses a first guidewire lumen extending along a first guidewire lumen axis and configured to track along a first guidewire. The first guidewire lumen axis is offset the central longitudinal axis. The stent graft delivery system further includes a tapered tip extending distally from the stent graft cover and defining an offset through-channel extending within the tapered tip along a tapered tip offset axis and configured to track along the first guidewire. The first guidewire lumen axis and the tapered tip offset axis extend along a common axis.
- According to another embodiment, a stent graft delivery system is disclosed. The stent graft delivery system includes a first guidewire lumen extending along a first guidewire lumen axis and is configured to track along a first guidewire. The system also includes a tapered tip defining an offset through-channel extending within the tapered tip along a tapered tip offset axis and configured to track along the first guidewire. The first guidewire lumen axis and the tapered tip offset axis extend along a common axis.
- According to yet another embodiment, a stent graft delivery system comprises a first guidewire lumen extending along a first guidewire lumen axis and configured to track along a first guidewire. The stent graft delivery system further includes a tapered tip defining an offset through-channel extending within the tapered tip along a tapered tip offset axis and configured to track along the first guidewire. The first guidewire lumen and the offset through-channel are fixed in alignment to receive the first guidewire.
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FIG. 1 is a schematic illustration of a stent graft delivery system, according to one embodiment. -
FIG. 2 is a rear perspective view of a distal end of the delivery system with an inner member removed and a stent graft cover partially transparent for view of the inner components, according to one embodiment. -
FIG. 3 is a rear view of the distal end of the delivery system from inside the delivery system, according to one embodiment. -
FIG. 4 is a side elevation view of the distal end of the delivery system with an opening in the stent graft cover for view of the inner components, according to one embodiment. -
FIG. 5 is a cross-sectional view of the distal end of the delivery system, according to one embodiment. -
FIG. 6 is a side view of a spindle configured to be positioned within the distal end of the delivery system, according to one embodiment. -
FIG. 7 is a side view of the spindle ofFIG. 6 placed about an inner member of the delivery system, according to one embodiment. -
FIG. 8 is a cross-sectional view of the tapered tip of the delivery system having a profile according to one embodiment. -
FIG. 9 is a cross-sectional view of the tapered tip of the delivery system having a profile according to another embodiment. -
FIG. 10 is a cross-sectional view of the tapered tip of the delivery system having a profile according to another embodiment. - Embodiments of the present disclosure are described herein. It is to be understood, however, that the disclosed embodiments are merely examples and other embodiments can take various and alternative forms. The figures are not necessarily to scale; some features could be exaggerated or minimized to show details of particular components. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a representative basis for teaching one skilled in the art to variously employ the embodiments. As those of ordinary skill in the art will understand, various features illustrated and described with reference to any one of the figures can be combined with features illustrated in one or more other figures to produce embodiments that are not explicitly illustrated or described. The combinations of features illustrated provide representative embodiments for typical applications. Various combinations and modifications of the features consistent with the teachings of this disclosure, however, could be desired for particular applications or implementations.
- Directional terms used herein are made with reference to the views and orientations shown in the exemplary figures. A central axis is shown in the figures and described below. Terms such as “outer” and “inner” are relative to the central axis. For example, an “outer” surface means that the surfaces faces away from the central axis, or is outboard of another “inner” surface. Terms such as “radial,” “diameter,” “circumference,” etc. also are relative to the central axis. The terms “front,” “rear,” “upper” and “lower” designate directions in the drawings to which reference is made.
- Unless otherwise indicated, for the delivery system the terms “distal” and “proximal” are used in the following description with respect to a position or direction relative to a treating clinician. “Distal” and “distally” are positions distant from or in a direction away from the clinician, and “proximal” and “proximally” are positions near or in a direction toward the clinician. For the stent-graft prosthesis, “proximal” is the portion nearer the heart by way of blood flow path while “distal” is the portion of the stent-graft further from the heart by way of blood flow path.
- The following detailed description is merely exemplary in nature and is not intended to limit the invention or the application and uses of the invention. Although the description is in the context of treatment of blood vessels such as the aorta, coronary, carotid and renal arteries, the invention may also be used in any other body passageways where it is deemed useful.
- Thoracic aortic aneurysms with disease progression extending into the aortic arch can be treated with a branched stent graft and delivery system. Branched stent graft delivery systems can be used to deliver and deploy stent grafts that are configured to couple with secondary stent grafts that extend into vessels or “branches” within a patient's vasculature, such as the thoracic aorta. For example, during a surgical procedure, a main guidewire may be fed into the vasculature and into a main vessel (e.g., aortic arch), and a secondary guidewire may be fed into a secondary vessel or branched artery (e.g., left subclavian). The stent graft delivery system can include a main lumen that tracks along the main guidewire, and a secondary lumen that tracks along the secondary guidewire. A main stent graft can be deployed in a main vessel, and a supplemental, secondary stent graft can be deployed in the branched artery. An example of such a surgical procedure is described in U.S. patent application Ser. No. 16/828,644 titled Branched Stent Graft Delivery System, which is hereby incorporated by reference.
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FIG. 1 shows a branched stentgraft delivery system 10 according to one embodiment. The branched stentgraft delivery system 10, also more simply referred to as a stent graft delivery system or a delivery system, includes an endovascular catheter and extends between aproximal end 12 and adistal end 14. The terms “proximal end” and “distal end” are not intended to be limiting, as a surgical clinician may, during a procedure, in fact be located closer to thedistal end 14 than theproximal end 12. Therefore, the proximal end and the distal end may be referred to as a “first end” and a “second end,” respectively. - A threaded
screw gear 16 extends along an axis between theproximal end 12 and thedistal end 14. The threaded screw gear may be a multi-part shell configured to connect together to make a tubular screw gear. In one embodiment, thescrew gear 16 is two half-shells configured to connect (e.g., snap or assemble) together. - A
handle assembly 18 is provided for grip by the clinician. Thehandle assembly 18 may include two separable portions, namely afront grip 20 and anexternal slider 22. Thefront grip 20 may be fixed relative to thescrew gear 16, and theexternal slider 22 may rotate about a threaded outer surface of thescrew gear 16 to move linearly along thescrew gear 16. For example, during deployment of a stent graft, theexternal slider 22 is rotated to move toward theproximal end 12. Since theexternal slider 22 is operatively coupled to a stent graft cover 24 surrounding the stent graft, thestent graft cover 24 is retracted with the linear movement of theexternal slider 22. Meanwhile, atip 26 at thedistal end 14 of thedelivery system 10, which has openings to track over the guidewires, can remain steady within the vessel as thestent graft cover 24 is retracted away from thetip 26. Retraction of thestent graft cover 24 allows the stent graft to expand within the patient's vessel. Once the stent graft is deployed, the entire stentgraft delivery system 10 may be retracted from the patent's vessel. - The stent graft can be self-expanding, in that it includes structures that are shaped or formed from a material that can be provided with a mechanical memory to return the structure from a compressed or constricted delivery configuration to an expanded deployed configuration. The stent graft can include two main components: a tubular graft, and one or more stents for supporting and expanding the graft. The graft may be formed from any suitable graft material, for example and not limited to, a low-porosity woven or knit polyester, DACRON material, expanded polytetrafluoroethylene, polyurethane, silicone, or other suitable materials. In another embodiment, the graft material can also be a natural material such as pericardium or another membranous tissue such as intestinal submucosa. The stent is radially-compressible and expandable, is coupled to the graft material for supporting the graft material, and is operable to self-expand into apposition with the interior wall of a body vessel (not shown). Each stent can be constructed from a self-expanding or spring material, such as but not limited to Nitinol, stainless steel, a pseudo-elastic metal such as a nickel titanium alloy or nitinol, various polymers, or a so-called super alloy, which may have a base metal of nickel, cobalt, chromium, or other metal, or other suitable material. This allows the stent graft to expand when the
stent graft cover 24 is retracted therefrom. The stent may be a sinusoidal patterned ring including a plurality of crowns or bends and a plurality of struts or straight segments with each crown being formed between a pair of opposing struts. - While the
screw gear 16 is illustrated and described herein as having a threaded outer surface, it should be understood that in other embodiments, the screw gear is not threaded, theexternal slider 22 can slide linearly along the screw gear, or any other suitable mechanism may be used to retract the graft cover. - The stent
graft delivery system 10 may also include anaccess port 28. Theaccess port 28 provides an opening for insertion, removal, or receiving of a secondary guidewire lumen, or branching lumen, for surrounding a secondary guidewire. Thedelivery system 10 can track along both the main guidewire and the secondary guidewire during delivery of the stent graft. -
FIGS. 2-5 illustrate various views of internal components of adistal end 100 of a stent graft delivery system, such as that illustrated inFIG. 1 . In other words, the structure shown inFIGS. 2-5 and described below can be substituted for thedistal end 14 ofFIG. 1 . - The
distal end 100 includes atip 102, also referred to as a tapered tip due to its tapered profile. The taperedtip 102 provides a leading edge of thedelivery system 10, and tracks over one or more guidewires. In particular, the taperedtip 102 includes a leading edge orfront surface 104 that defines a cut-out or opening 106 configured to receive a main guidewire. Theopening 106 can be an aperture in the material of the taperedtip 102 with an inner surface of the taperedtip 102 surrounding the main guidewire. Theopening 106 is aligned with aninner member 108 within thestent graft cover 24, as will be described below. - The tapered
tip 102 can also include asecond opening 110 configured to receive a secondary guidewire. Thissecond opening 110 allows thedelivery system 10 to track over the secondary guidewire simultaneously with the main guidewire. Thesecond opening 110 is aligned with asecondary lumen 112 within thestent graft cover 24, as will be described below. - The
stent graft cover 24 is the outer-most sheath or lumen of the stent graft delivery system. The stent graft cover initially contains or surrounds a proximal portion of the taperedtip 102, as well as theinner member 108, thesecondary lumen 112, and a stent graft (not shown). As explained above, after insertion of thedelivery system 10 to a desired location within the patient's vasculature, the surgical technician may utilize the handle to retract thestent graft cover 24, allowing the stent graft to deploy. Thestent graft cover 24 is an elongate tubular member defining a lumen from a proximal end to a distal end thereof. Thestent graft cover 24 may be formed from a plurality of different materials or combination of materials; in one embodiment, thestent graft cover 24 is formed with a braided stainless steel wire with a flat or rounded cross section that is sandwiched between layers of PEBAX® or VESTAMID®. - The
inner member 108 defines a hollow lumen, and can be two parts. For example, theinner member 108 can include an inner lumen orguidewire lumen 114, and an outer lumen orcapture lumen 116. Each of theguidewire lumen 114 and thecapture lumen 116 may be made from a high tensile polymer, such as polyether ether ketone (PEEK) or a polyimide. Thecapture lumen 116 is larger than theguidewire lumen 114 and receives theguidewire lumen 114 therein. Theguidewire lumen 114 may be fixed to the taperedtip 102, while thecapture lumen 116 may be slideable along the outer surface of the guidewire lumen to slide toward the proximal end of thedelivery system 10. Theguidewire lumen 114 may be fixed in alignment with theopening 106 of the taperedtip 102 to receive the main guidewire therethrough and track along the main guidewire during insertion into the patient. - The delivery system also includes a tip capture mechanism, shown generally at 120. The
tip capture mechanism 120 is coupled to, and actuated by, theinner member 108. In particular, according to the illustrated embodiment, thetip capture mechanism 120 includes a capture fitting 122 having a plurality offingers 124 or prongs. The capture fitting 122 is configured to hold a stent, ring, loop, or other such structure of a proximal end of the stent graft. This allows the stent graft to be deployed (e.g., when thestent graft cover 24 is retracted) while its proximal end is held in a constricted manner during deployment. A proximal end of the capture fitting 122 is fixed to thecapture lumen 116 to move with thecapture lumen 116. Once the stent graft is at least partially deployed, thecapture lumen 116 can be slid toward the surgical technician relative to theguidewire lumen 114, thereby releasing thefingers 124 of the tip capture fitting 122 from the stent, ring, loop, or the like of the stent graft. This releases the stent graft from the delivery system, and the entire catheter can then be removed from the patient. While one example of a tip capture mechanism has been described, any tip capture mechanism may be compatible with the present disclosure. For example, the tip capture mechanism may be configured such that the inner tube extends axially forward to move the tip forward relative to the outer tube and spindle, thereby releasing the stent graft. Other tip capture mechanisms may include a single tube, three or more tubes, or other systems. - The
secondary lumen 112 is also provided within thestent graft cover 24. Thesecondary lumen 112 is aligned with theopening 110 to receive the secondary guidewire therethrough, and track along the secondary guidewire during insertion into the patient's vasculature. The secondary lumen may be located radially outboard of theinner member 108, but radially inward of thestent graft cover 24. - In previous designs of stent graft delivery systems, the addition of a secondary lumen within the confines of the stent graft could present several issues. For example, packaging constraints within the delivery system would be compromised, requiring other components within the confines of the stent graft to be reduced in size while still maintaining feasibility. Moreover, a bulge could be created in the stent graft cover as the secondary lumen is bent around the stent graft components. Such a bulge can make the profile of the delivery system lager than the intended outer profile. There is also difficulty in maintaining alignment of the secondary lumen and the inner components. In many cases, the secondary lumen is forced to bend around the arms of the capture mechanism and can become bent or misshapen in a way that could compromise the lumen patency or at least increase wire friction through the lumen.
- Therefore, according to various embodiments described herein, the tapered
tip 102 is designed to allow for smaller components within the confines of thestent graft cover 24. In embodiments, thefront surface 104 and theopening 106 at the distal end of the taperedtip 102 is not concentric with thestent graft cover 24. This allows other components of the delivery system, such as theinner member 108 andtip capture mechanism 120, to also assume a location that is not concentric with thestent graft cover 24. These components can be offset from center in a direction away from thesecondary lumen 112, giving more space for thesecondary lumen 112 to assume and not be bent or create a bulge in thestent graft cover 24. Also, this allows an easier retraction of thesecondary lumen 112, if necessary, during a surgical deployment prior to retraction of thestent graft cover 24. - The nature of the offset can be seen in the
FIGS. 4 and 5 , and in particularFIG. 4 . The distal surface orfront surface 104, theopening 106, theinner member 108, and thetip capture mechanism 120 are all concentric and have a common firstcentral axis 130. Meanwhile, thestent graft cover 24 has a secondcentral axis 132 that is offset from the firstcentral axis 130. Thesecondary lumen 112 is positioned toward the perimeter (e.g., touching or adjacent) of thestent graft cover 24. The firstcentral axis 130 is located away from the secondcentral axis 132 in a direction away from the secondcentral axis 132. While the terms “first” and “second” are used herein, it should be understood that these terms are used merely to delineate and label the two components separately, and the terms can be interchangeable. - To accommodate for this offset-axis relationship, the internal components may be reduced in size. For example, the
tip capture mechanism 120 may be reduced in size, to allow the components to be offset from their original, central positioning. This creates more space for thesecondary lumen 112. - This also allows for the tapered
tip 102 to be assembled to (e.g., pressed into) the delivery system late in the assembly process, in which the taperedtip 102 can be precisely positioned, rotationally, to optimize engagement with thesecondary lumen 112. In other words, once thesecondary lumen 112 is assembled and in place within thestent graft cover 24, the taperedtip 102 can be assembled to the remainder of the delivery system at a rotational alignment such that theopening 110 is aligned with thesecondary lumen 112. - To facilitate attachment during assembly, a
spindle 140 is provided. Thespindle 140 is a barbed insert for attachment of the taperedtip 102 to theinner member 108. Thespindle 140 is shown in the cross-sectional view inFIG. 5 , in isolation inFIG. 6 and attached about theguidewire lumen 114 inFIG. 7 . Thespindle 140 is configured to align with thetip capture device 120 along the firstcentral axis 130 to hold the stent graft in place during delivery (e.g., the stent apices may be held between thespindle 140 and the capture fitting 122). Thespindle 140 is fixed to the taperedtip 102, and does not move with thecapture lumen 116 or stent graft cover 24 during deployment of the stent graft. In previous designs, a spindle was overmolded onto a tapered tip, but this can create difficulty with non-concentric arrangements. Instead, in embodiments herein thespindle 140 is a separate component and separately assembled to the taperedtip 102. - In one embodiment, a portion of the delivery system may be pre-assembled or pre-loaded such that the tapered
tip 102 may be assembled to theguidewire lumen 114, which is inserted into thecapture lumen 116, and the taperedtip 102 is pressed onto thespindle 140. This eliminates a need for any threaded screw fit, and instead provides a simple press-fit attachment between thetapered tip 102 and thespindle 140. The taperedtip 102 may be formed to include aninner surface 142 that creates a widened portion of theopening 106 at a proximal end of the taperedtip 102. Theinner surface 142 of the widened opening can be pressed around and fit about anexterior surface 144 of thespindle 140. - To facilitate the press-fit attachment, the
exterior surface 144 of thespindle 140 may be provided with surface features configured to inhibit movement. In particular, theexterior surface 144 can include a first set ofbarbs 146 and a second set ofbarbs 148. The first set ofbarbs 146 may include one or more fins, projections, or the like that extend annularly about the firstcentral axis 130. As can be seen inFIGS. 6-7 , thesebarbs 146 may be formed to be angled such that a proximal end of thebarbs 146 extends further radially outward compared to a distal end of thebarb 146. This angle inhibits the taperedtip 102 from pulling away from thespindle 140 after assembly. Thebarbs 146 may be flattened or otherwise compressed once the taperedtip 102 is pressed over thebarbs 146. - The second set of
barbs 148 may include one or more circumferentially-spaced fins each extending in an axial direction along theexterior surface 144. Thesebarbs 148 are configured to inhibit rotation between thetapered tip 102 and thespindle 140. - To facilitate the press-fit attachment between the
guidewire lumen 114 and the taperedtip 102, the exterior surface of theguidewire lumen 114 may be provided with one ormore barbs 150. Thebarbs 150 may be similar to the first set ofbarbs 146, being disposed annularly about the firstcentral axis 130. While not shown, theguidewire lumen 114 may also be provided with one or more barb that is similar in design to the second set ofbarbs 148. - As can be seen in
FIGS. 4 and 5 , the offset-axis relationship of the delivery system can yield a tapered tip with varying thicknesses of material. For example, referring toFIG. 5 , the taperedtip 102 has a thicker amount of material above theopening 106 than below. Said another way, there is more material of the tapered tip on the side of the firstcentral axis 130 closer to thesecond opening 110 than the other side of the firstcentral axis 130. The firstcentral axis 130 is not the centerline of the taper of the taperedtip 102.FIGS. 8-10 illustrate various embodiments for varying the thickness of the tapered tip on either side of theopening 106. Varying the shape or thickness of the taperedtip 102 can provide a preferential bending direction during insertion into the vasculature. - The tapered tips of
FIGS. 8-10 include the structure of the taperedtip 102 described above, unless described otherwise.FIG. 8 shows a taperedtip 102′ according to one embodiment. The taperedtip 102′ has afirst portion 160 on the side of theopening 106 closer to thesecond opening 110, and asecond portion 162 on the side of theopening 106 away from thesecond opening 110. Thefirst portion 160 is generally conical in shape, generally constantly increasing in thickness (e.g., between theopening 106 and the outer surface) from thefront surface 104 toward the rear. The outer surface of thefirst portion 160 is generally linear. Meanwhile, thesecond portion 162 has an outer surface that is concave. Therefore, thesecond portion 162 is not generally conical in shape, as the thickness of the second portion is not constant. This can influence the tracking performance of the delivery system in a first manner, with a first preferred bending direction that may allow for easier tracking and device placement. -
FIG. 9 shows a taperedtip 102″ according to another embodiment. The taperedtip 102″ has afirst portion 170 on the side of theopening 106 closer to thesecond opening 110, and asecond portion 172 on the side of theopening 106 away from thesecond opening 110. Thefirst portion 170 has an outer surface that is generally concave, and thesecond portion 172 has an outer surface that is generally concave. The outer surfaces of the twoportions second portion 172 can be more concave than thefirst portion 170. Moreover, the outer surfaces of both the first andsecond portions portions -
FIG. 10 shows a taperedtip 102″′ according to another embodiment. The taperedtip 102″′ has afirst portion 180 on the side of theopening 106 closer to thesecond opening 110, and asecond portion 182 on the side of theopening 106 away from thesecond opening 110. Thesecond portion 182 may have an outer surface that is generally linear, creating a conical shape of thesecond portion 182. Meanwhile, the outer surface of thefirst portion 170 may be concave. Opposite to the embodiment ofFIG. 8 , in this embodiment, the thickness of thesecond portion 182 may exceed the thickness of thefirst portion 180 for at least a majority of the length of theportions - While exemplary embodiments are described above, it is not intended that these embodiments describe all possible forms encompassed by the claims. The words used in the specification are words of description rather than limitation, and it is understood that various changes can be made without departing from the spirit and scope of the disclosure. As previously described, the features of various embodiments can be combined to form further embodiments of the invention that may not be explicitly described or illustrated. While various embodiments could have been described as providing advantages or being preferred over other embodiments or prior art implementations with respect to one or more desired characteristics, those of ordinary skill in the art recognize that one or more features or characteristics can be compromised to achieve desired overall system attributes, which depend on the specific application and implementation. These attributes can include, but are not limited to cost, strength, durability, life cycle cost, marketability, appearance, packaging, size, serviceability, weight, manufacturability, ease of assembly, etc. As such, to the extent any embodiments are described as less desirable than other embodiments or prior art implementations with respect to one or more characteristics, these embodiments are not outside the scope of the disclosure and can be desirable for particular applications.
Claims (20)
1. A stent graft delivery system comprising:
a stent graft cover having a central longitudinal axis, the stent graft cover houses a first guidewire lumen extending along a first guidewire lumen axis and configured to track along a first guidewire, the first guidewire lumen axis is offset the central longitudinal axis; and
a tapered tip extending distally from the stent graft cover and defining an offset through-channel extending within the tapered tip along a tapered tip offset axis and configured to track along the first guidewire,
the first guidewire lumen axis and the tapered tip offset axis extend along a common axis.
2. The stent graft delivery system of claim 1 , wherein the tapered tip includes a base portion and a tapered portion extending from the base portion, the base portion situated partially situated within a distal portion of the stent graft cover, and the offset through-channel extending within the base portion and the tapered portion.
3. The stent graft delivery system of claim 2 , wherein the first guidewire lumen includes a distal portion extending within the base portion of the tapered tip.
4. The stent graft delivery system of claim 3 , wherein the distal portion of the first guidewire lumen terminates within the base portion.
5. The stent graft delivery system of claim 3 , wherein the distal portion of the first guidewire lumen terminated within the stent graft cover.
6. The stent graft delivery system of claim 1 , wherein the stent graft cover housing a secondary lumen extending along a secondary lumen axis offset the first guidewire lumen axis.
7. The stent graft delivery system of claim 6 , wherein the tapered tip has a secondary opening extending along a secondary opening axis, and the secondary opening is aligned with the secondary lumen.
8. A stent graft delivery system comprising:
a first guidewire lumen extending along a first guidewire lumen axis and configured to track along a first guidewire; and
a tapered tip defining an offset through-channel extending within the tapered tip along a tapered tip offset axis and configured to track along the first guidewire,
the first guidewire lumen axis and the tapered tip offset axis extend along a common axis.
9. The stent graft delivery system of claim 8 , wherein the tapered tip includes a cross section including the tapered tip offset axis.
10. The stent graft delivery system of claim 9 , wherein the cross section includes a first side above the offset through-channel and having a first profile and a second side below the offset through-channel and having a second profile.
11. The stent graft delivery system of claim 10 , wherein the first profile is a linear-shaped profile.
12. The stent graft delivery system of claim 10 , wherein the second profile is concave profile.
13. The stent graft delivery system of claim 10 , wherein the first profile is a concave profile.
14. The stent graft delivery system of claim 8 , wherein the tapered tip further defines a peripheral through-channel extending within the tapered tip and along a peripheral axis offset the tapered tip offset axis.
15. A stent graft delivery system comprising:
a first guidewire lumen extending along a first guidewire lumen axis and configured to track along a first guidewire; and
a tapered tip defining an offset through-channel extending within the tapered tip along a tapered tip offset axis and configured to track along the first guidewire,
the first guidewire lumen and the offset through-channel are fixed in alignment to receive the first guidewire.
16. The stent graft delivery system of claim 15 , wherein the first guidewire lumen is fixed to the tapered tip.
17. The stent graft delivery system of claim 15 , further comprising a capture lumen configured to slide along an outer surface of the first guidewire lumen.
18. The stent graft delivery system of claim 15 , wherein the tapered tip has a thicker amount of material above the offset through-channel than below the offset through-channel.
19. The stent graft delivery system of claim 15 , wherein the tapered tip has a tapered tip central axis, and the tapered tip offset axis is offset the tapered tip central axis.
20. The stent graft delivery system of claim 15 , wherein the tapered tip includes a first bending direction and a second bending direction, and the tapered tip bends easier in the first bending direction than the second bending direction.
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US16/862,720 Active 2040-10-04 US11612505B2 (en) | 2020-04-30 | 2020-04-30 | Stent graft delivery system with offset tapered tip |
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IE20020533A1 (en) | 2001-06-27 | 2003-05-28 | Salviac Ltd | A Catheter |
US20030109886A1 (en) | 2001-06-27 | 2003-06-12 | Martin Keegan | Catheter |
US6999809B2 (en) | 2002-07-16 | 2006-02-14 | Edwards Lifesciences Corporation | Central venous catheter having a soft tip and fiber optics |
WO2004089249A1 (en) * | 2003-04-03 | 2004-10-21 | William A. Cook Australia Pty. Ltd. | Branch stent graft deployment and method |
US7763063B2 (en) * | 2003-09-03 | 2010-07-27 | Bolton Medical, Inc. | Self-aligning stent graft delivery system, kit, and method |
US8216298B2 (en) * | 2007-01-05 | 2012-07-10 | Medtronic Vascular, Inc. | Branch vessel graft method and delivery system |
US7727251B2 (en) * | 2007-04-25 | 2010-06-01 | Medtronic Vascular, Inc. | Low profile dilator for arteriotomy closure system |
EP2036519A1 (en) * | 2007-09-16 | 2009-03-18 | Ophir Perelson | Bifurcation stent and stent delivery assembly |
US8419782B2 (en) * | 2009-04-09 | 2013-04-16 | Medtronic Vascular, Inc. | Precise positioning prosthesis delivery system and method |
US8764811B2 (en) | 2010-04-20 | 2014-07-01 | Medtronic Vascular, Inc. | Controlled tip release stent graft delivery system and method |
US8920485B2 (en) | 2012-04-13 | 2014-12-30 | Medtronic Vascular, Inc. | Stent-graft delivery system having a rotatable single shaft tip capture mechanism |
US11406497B2 (en) * | 2013-03-14 | 2022-08-09 | Jc Medical, Inc. | Heart valve prosthesis |
US9486350B2 (en) | 2014-03-31 | 2016-11-08 | Medtronic Vascular, Inc. | Stent-graft delivery system having handle mechanism for two-stage tip release |
CN111529126A (en) * | 2015-06-30 | 2020-08-14 | 恩朵罗杰克斯股份有限公司 | Systems and methods for securing a first elongate member to a second elongate member |
US10195392B2 (en) * | 2015-07-02 | 2019-02-05 | Boston Scientific Scimed, Inc. | Clip-on catheter |
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US11612505B2 (en) | 2023-03-28 |
EP3903746A3 (en) | 2022-02-16 |
EP3903746A2 (en) | 2021-11-03 |
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